The American Institute of Biological Sciences (AIBS) appreciates the opportunity to comment on the Environmental Protection Agency's (EPA) proposed rule: "Strengthening Transparency in Regulatory Science." We thank EPA for extending the initial 30-day public comment period and scheduling a public hearing on the proposed rule. We support the objective of increased transparency in the rulemaking process, but the proposed rule is inadequately defined and thus itself lacks transparency and appropriate public protections. We request that EPA rescind the proposed rule and initiate an open process for gathering the information required to more thoroughly articulate a proposed rule.

Any proposal to increase transparency in the regulatory process must not arbitrarily exclude important scientific information from the decision-making process. Nor can personal information about individuals, such as their genetic information or health status, be sacrificed. A failure to protect these data will hinder future scientific investigations as people will refuse to participate in research studies if they are not confident that their most personal information is protected.

Importantly, scientific journals take steps to protect personal information. We are not aware of any secure way to mask or protect personally identifiable information in the public domain, and therefore think that any rule requiring this information be made public is needlessly risky. These data are important, however, to informing the decision-making process and should not be excluded from rule-making processes because they are not publicly disclosed.

As part of this request for comment, EPA has solicited input on measures to "provide protected access to identifiable and sensitive data." This is a significant issue and one that EPA should fully understand prior to moving forward with any new rule. Time and expertise are required to identify and properly evaluate the feasibility, cost, and effectiveness of potential actions. It is unlikely that EPA can effectively gather and evaluate this information in the time prescribed by the proposed rule. We recommend that EPA initiate a formal request for public comment on this issue alone and use what is learned to help inform and guide any potential future rule on transparency.

High-quality, curated, and vetted metadata are generally required for someone else to appropriately re-analyze or use data such as those that would be made available via the proposed rule. The proposal is silent on metadata standards and practices. This is a significant challenge and another major problem with the proposed rule.

We support EPA's goal of conducting independent peer-reviews of the science and data used to inform regulatory decisions, but think this section lacks adequate specificity. Who will conduct and manage the peer-review process? Will these reviews be managed by the Office of Research and Development or by the various regulatory offices within EPA? Does EPA have appropriate staffing, expertise, and resources to manage these peer-reviews? We recommend that EPA partner with scientific organizations and professional communities to administer and manage these reviews. Such outsourcing and partnerships will help to ensure that EPA gains access to independent and highly qualified experts; and will promote greater public confidence in the independence of these peer-reviews. This kind of process for managing peer-review will also allow EPA to more cost-effectively, nimbly, and rapidly conduct reviews as it will not require EPA to substantially increase staffing for convening reviews. Such a process will also provide EPA with greater capacity to conduct reviews on timescales that do not needlessly delay regulatory and rulemaking schedules.

After reviewing this proposed rule, AIBS respectfully urges EPA to rescind the current proposal. We ask that EPA initiate a new, transparent, and interactive process with the scientific, public health, and environmental management communities, as well as other appropriate stakeholders to identify responsible and viable approaches for promoting greater understanding of the science and data used to inform EPA decision-making.

Thank you for your consideration of these concerns. Please do not hesitate to contact me if AIBS can be of further assistance on this important matter.